MAUDE Adverse Event Report: IRIS INTERNATIONAL ICHEM VELOCITY; AUTOMATED URINE CHEMISTRY ANALYZER

Catalog Number 700-7177-001

Device Problems False Negative Result (1225); Failure to Prime (1492); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/19/2014

Event Type  malfunction  

Event Description

Customer reported issues with false negative blood reporting.

Manufacturer Narrative

Ichem velocity urine chemistry reported false negative blood for pt samples.Two samples were reported out to the physician.It is unk if pt management was changed as a result.Fse noticed the analyzer was becoming de-primed during normal operation, leading to air bubbles in tubing.Fluid block assembly was replaced and instrument stayed primed.Fse completed velocity performance verification checklist and system was operational.Upon further investigation, 2 pt samples on urine chemistry reported false negative for blood and these results were reported out to the physician.It is unk at the present time if there was a change in pt management as a result.

• Brand Name: ICHEM VELOCITY
• Type of Device: AUTOMATED URINE CHEMISTRY ANALYZER
• Manufacturer (Section D): IRIS INTERNATIONAL; 9172 eton ave.; chatsworth CA 91311
• Manufacturer Contact: sudha gupta ; 9172 eton ave.; chatsworth, CA 91311 ; 8185277272
• MDR Report Key: 4272840
• MDR Text Key: 5228945
• Report Number: 2023446-2014-00157
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 700-7177-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2014
• Initial Date FDA Received: 10/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1